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Infliximab and Anti-Infliximab Antibody (Serial Monitor), DoseASSURE™ IFX

CPT: 80230; 82397
80299; 82397
80230; 82397
Updated on 01/29/2020
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Synonyms

  • Anti-TNF-alpha Drug
  • DoseASSURE
  • IFD
  • Remicade

Special Instructions

To order this test without the serial monitor service, use 503770. For a complete test description, see Infliximab Concentration and Anti-Infliximab Antibody [503770].


Expected Turnaround Time

5 - 10 days



Specimen Requirements


Specimen

Serum


Volume

2 mL


Minimum Volume

1 mL (Note: This volume does not allow for repeat testing).


Container

Red-top tube or gel-barrier tube


Collection

Serum must be separated from cells within 45 minutes of venipuncture. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Frozen (preferred) or refrigerated


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

7 days

Frozen

359 days

Freeze/thaw cycles

Stable x6


Test Details


Use

Provides infliximab drug concentration levels as well as levels of anti-infliximab antibodies.

In the absence of anti-infliximab antibodies, the infliximab drug level typically reflects the total infliximab concentration in serum. In the presence of anti-infliximab antibodies, the infliximab drug level typically reflects the antibody-unbound fraction of infliximab concentration in serum. The presence of infliximab drug, even at concentrations well above target treatment levels (>50 ug/mL), does not interfere with the anti-infliximab antibody detection. This assay may be helpful for any patients on infliximab therapy for diseases such as Crohn's disease, inflammatory bowel disease, ulcerative colitis, rhematoid arthritis, or other autoimmune conditions. This test includes long-term serial monitoring of results.


Limitations

Failure of infliximab therapy may not always be due to the presence of anti-infliximab antibodies. In addition, the absence of anti-infliximab antibodies does not guarantee positive response to treatment.


Methodology

Electrochemiluminescence Immunoassay (ECLIA)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
503870 Infliximab+Ab (Serial Monitor) 503772 Infliximab Drug Level ug/mL 39803-2
503870 Infliximab+Ab (Serial Monitor) 503773 Anti-Infliximab Antibody ng/mL 72623-2
Reflex Table for Anti-Infliximab Antibody
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 000000 Serial Monitoring 000000 Serial Monitoring N/A

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